Cosyntropin

FDA label, Amphastar Pharmaceuticals, Inc., intramuscular, effective 2025-01-30. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Adrenocorticotropic Hormone

Dosing in kidney impairment

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Preparation and administration

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Basis

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Reconstitution Instructions Aseptically reconstitute the lyophilized powder in the vial using 1 mL of 0.9% Sodium Chloride Injection, USP and gently swirl. After reconstitution, the final concentration of CORTROSYN reconstituted solution is 0.25 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The reconstituted CORTROSYN solution should be clear and colorless, and free of particulates. If CORTROSYN solution is cloudy or contains particulates, do not administer. If the CORTROSYN reconstituted solution is not used immediately, discard the unused CORTROSYN reconstituted solution.

Administration Information CORTROSYN may be administered by intramuscular or intravenous injection. Obtain blood sample for baseline serum cortisol. Obtain blood samples again for assessment of cortisol levels exactly 30 minutes and 60 minutes after administration of CORTROSYN.

Table 1. Recommended CORTROSYN Dose for Pediatric Patients
AgeRecommended Dose Volume of Reconstituted Solution
Birth to less than 2 years 0.125 mg 0.5 mL
2 to 17 years 0.25 mg 1 mL

Drug interactions

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Label text (3 paragraphs)

Drug effects on plasma cortisol levels: ◦ Accuracy of the test results can be affected by concomitant medications. ◦ Glucocorticoids and spironolactone: May falsely elevate plasma cortisol levels. Stop these drugs on day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing. (7) ◦ Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before CORTROSYN testing. (7)

7.1 Drug Effects on Plasma Cortisol Levels Accuracy of the test results can be affected by concomitant medications. Plasma cortisol levels and subsequent diagnosis of adrenocortical insufficiency following CORTROSYN administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)]. Glucocorticoids and spironolactone: May falsely elevate plasma cortisol levels. Stop these drugs on the day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing.

Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before CORTROSYN testing to allow cortisol binding globulin levels to return to levels within the reference range. Alternatively, concomitant measurement of cortisol binding globulin at the time of testing can be done; if cortisol binding globulin levels are elevated, plasma total cortisol levels are considered inaccurate.

Contraindications

4 CONTRAINDICATIONS CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)]. CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis. (4, 5.1)

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

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Supply and cost

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